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Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

NCT ID: NCT03607396

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-01

Brief Summary

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The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
* Diagnosis of Cystic Fibrosis confirmed
* Chronic infection by Pseudomonas aeruginosa
* Patients can be treated with any inhaled antibiotic before or after AZLI treatment
* Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
* For lung transplant patiens, only data before the transplant will be collected.

Exclusion Criteria

* Non applicable
Minimum Eligible Age

6 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital La Fe

Valencia, Valencia, Spain

Site Status NOT_YET_RECRUITING

Hospital 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Olga SanchezMaroto

Role: CONTACT

Phone: 934893000

Email: [email protected]

Facility Contacts

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Aurora Fernandez

Role: primary

Emilio Monte

Role: primary

Carmen Luna, MD

Role: primary

Other Identifiers

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AFP-AZT-2017-01

Identifier Type: -

Identifier Source: org_study_id